BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2346563 · Received November 22, 2011

    Report

    Report Number
    2050012-2011-07853
    Event Type
    Malfunction
    Date Received
    November 22, 2011
    Date of Event
    October 26, 2011
    Report Date
    October 26, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTED THAT THE SAMPLE PROBE ISSUE WAS RESOLVED. BEC HAS NO INFORMATION ON HOW CUSTOMER RESOLVED THE ISSUE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE CARTRIDGE CHEMISTRY (CC) SAMPLE PROBE OF THE UNICEL DXC 600 SYNCHRON SYSTEM WAS LEAKING. CUSTOMER REPORTED THAT SHE DISCOVERED THE LEAK WHEN SHE RAN CONTROLS AND OBTAINED VERY LOW RESULTS ON ALL THE CC CHEMISTRIES. CUSTOMER REPORTED THAT THE CC SAMPLE SYRINGE WAS LOOSE AT THE BASE WHERE IT CONNECTS TO THE BROWN SYRINGE GUIDE, AND THAT THE SYRINGE WAS LEAKING AS WELL. CUSTOMER REPORTED THAT SHE TIGHTENED THE SYRINGE GUIDE BUT WAS UNABLE TO STOP THE SYRINGE AND THE PROBE FROM LEAKING. CUSTOMER REPORTED THAT ON THE DAY OF THE EVENT, SHE HAD PERFORMED THE THREE MONTH MAINTENANCE ON THE DXC 600 AND HAD REPLACED THE SYRINGE PLUNGERS. THE CUSTOMER REPORTED THAT SHE REVIEWED PATIENT RESULTS PRIOR TO THE INCIDENT AND FOUND TWO FALSE LOW LACTATE (LACT) RESULTS AND ONE FALSE LOW VANCOMYCIN (VANC) RESULT GENERATED ON THREE DIFFERENT PATIENT SAMPLES. CUSTOMER REPORTED THAT THE PATIENT SAMPLES WERE RUN ON THE SAME SHIFT. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER REPORTED THAT WHEN SHE REALIZED THAT THE PROBE WAS LEAKING, SHE SENT THE SAMPLES TO TEST ON A DIFFERENT DXC INSTRUMENT FROM ANOTHER CAMPUS, AND RECEIVED HIGHER RESULTS FOR ALL THREE PATIENT SAMPLES. CUSTOMER REPORTED THAT THE ERRONEOUS RESULTS WERE AMENDED. CUSTOMER REPORTED THAT PATIENT TREATMENT WAS NOT ALTERED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600 SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1